Back to resultsA Study of KER-050 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
Primary Purpose
Myelodysplastic Syndromes, Cytopenia
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KER-050
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring transfusion
Eligibility Criteria
Key Inclusion Criteria:
- Diagnosis of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease.
- < 5% blasts in bone marrow.
- Peripheral blood white blood cell (WBC) count < 13,000/µL.
Anemia defined as:
- In non-transfused participants, having received no red blood cell (RBC) transfusions within 8 weeks Hgb concentration ≤ 10.0 g/dL OR
- In LTB participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL within 8 weeks OR
- In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.
- Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.
Key Exclusion Criteria:
- Any active infection requiring parenteral antibiotic therapy within 28 days prior to Cycle 1 Day 1 or oral antibiotics within 14 days of Cycle 1 Day 1.
- Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- Vitamin B12 deficiency.
- Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
Treatment within 28 days prior to Cycle 1 Day 1 with:
- Erythropoiesis stimulating agent (ESA) OR
- Granulocyte colony-stimulating factor (G-CSF) OR
- Granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
- Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
- Treatment with another investigational drug or device or approved therapy for investigational use < or = 28 days prior to Cycle 1 Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer.
- Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
- Transferrin saturation < 15%.
- Ferritin < 50 µg/L.
- Folate < 4.5 nmol/L (< 2.0 ng/mL).
- Vitamin B12 < 148 pmol/L (< 200 pg/mL).
- Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
- Pregnant or lactating females.
Sites / Locations
- University of Miami, Sylvester Comprehensive Cancer CenterRecruiting
- H. Lee Moffitt Cancer Center and Research Center
- University of Pittsburgh Medical Health Center
- Border Medical Oncology Research UnitRecruiting
- The Tweed HospitalRecruiting
- Westmead HospitalRecruiting
- Townsville University HospitalRecruiting
- Royal Adelaide HospitalRecruiting
- Flinders Medical CentreRecruiting
- Box Hill HospitalRecruiting
- University Hospital GeelongRecruiting
- Austin HealthRecruiting
- Royal Melbourne HospitalRecruiting
- St Vincent's Hospital MelbourneRecruiting
- Ballarat Oncology and Haematology ServiceRecruiting
- Fakultni Nemocnice BrnoRecruiting
- Fakultni Nemocnice Kralovske VinohradyRecruiting
- Vseobecna Fakultni Nemocnice PrahaRecruiting
- CHU Angers - Hôpital Hôtel DieuRecruiting
- CHU de Nantes - Hotel DieuRecruiting
- CHU Nice - Hôpital de l'ArchetRecruiting
- Hôpital Saint-LouisRecruiting
- CH René-DubosRecruiting
- CHU de Bordeaux - Hôpital Haut-LévêqueRecruiting
- Centre Hospitalier de la Région d'AnnecyRecruiting
- Klinikum Bayreuth GmbHRecruiting
- Marien Hospital Dusseldorf GMBHRecruiting
- Universitaetsklinikum Duesseldorf AoeRRecruiting
- Klinikum Esslingen GmbHRecruiting
- Universitaetsklinikum Leipzig AoeRRecruiting
- Universitaetsmedizin der Johannes Gutenberg-Universitaet MainzRecruiting
- Universitaetsmedizin RostockRecruiting
- Sheba Medical CenterRecruiting
- Tel-Aviv Sourasky Medical CenterRecruiting
- Middlemore HospitalRecruiting
- Hospital Universitario Central de AsturiasRecruiting
- Hospital Universitario Vall d'HebronRecruiting
- ICO l'Hospitalet - Hospital Duran i ReynalsRecruiting
- Hospital Universitario de SalamancaRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- Hospital Universitari i Politecnic La FeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
KER-050 Cohort 1
KER-050 Cohort 2
KER-050 Cohort 3
KER-050 Cohort 4
KER-050 Cohort 5
KER-050 Dose Confirmation Cohort
Arm Description
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 4 cycles. Participants have the option to continue to receive KER-050 once 4 cycles have been completed for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 4 cycles. Participants have the option to continue to receive KER-050 once 4 cycles have been completed for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Participants to receive KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Type, frequency, severity of AEs and relationship of AEs to KER-050
Secondary Outcome Measures
Maximum concentrations of KER-050
Pharmacokinetics of KER-050
Erythroid response in low-transfusion burden (LTB) and high-transfusion burden (HTB) participants.
In LTB participants, the proportion of participants who have a hemoglobin increase of ≥ 1.5 g/dL from Baseline for ≥ 14 days (in the absence of RBC transfusions).
In HTB participants, the proportion of participants having a reduction of ≥ 50% or ≥ 4 RBC units transfused compared to pretreatment over an 8-week period.
Incidence of progression to higher risk MDS or AML per World Health Organization 2016 criteria
Change in baseline laboratory assessments prior to treatment with KER-050 and after treatment with KER-050
Incidence of progression to higher risk MDS or AML per World Health Organization 2016 criteria
Change in baseline bone marrow assessments prior to treatment with KER-050 and after treatment with KER-050
Modified 2006 International Working Group (IWG) Hematologic Improvement Erythroid (HI-E) response
In LTB participants, the proportion of participants with an increase of ≥ 1.5 g/dL from pretreatment hemoglobin during any 8-week period on study compared to Baseline.
In HTB participants, the proportion of participants having a reduction by ≥ 4 units of RBCs transfused (for a hemoglobin ≤ 9.0 g/dL) during any 8-week period on study, compared with the 8-week period prior to study Cycle 1 Day 1.
Mean change from baseline in hemoglobin
Change in baseline hemoglobin prior to treatment with KER-050 and after treatment with KER-050
Time to erythroid response and modified 2006 IWG HI-E response
Time to erythroid response prior to treatment with KER-050 and after treatment with KER-050
Duration of erythroid response and modified 2006 IWG HI-E response
Duration of erythroid response prior to treatment with KER-050 and after treatment with KER-050
Frequency of red blood cell (RBC) transfusions and rate of RBC transfusion independence ≥ 8 weeks
Frequency and rate of RBC transfusions prior to treatment with KER-050 and after treatment with KER-050
Change from Baseline in RBC counts and reticulocytes
Change in baseline RBC counts and reticulocytes prior to treatment with KER-050 and after treatment with KER-050
Full Information
NCT ID
NCT04419649
First Posted
June 3, 2020
Last Updated
September 28, 2023
Sponsor
Keros Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04419649
Brief Title
A Study of KER-050 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
Official Title
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keros Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of KER-050 on anemia in patients with very low, low or intermediate risk MDS.
Detailed Description
KER-050 is a therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins to promote hematopoiesis. It is being developed for the treatment of low blood cell counts, or cytopenias including anemia and thrombocytopenia in patients with Myelodysplastic Syndrome (MDS) and Myelofibrosis (MF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Cytopenia
Keywords
transfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Ascending dose study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KER-050 Cohort 1
Arm Type
Experimental
Arm Description
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 4 cycles. Participants have the option to continue to receive KER-050 once 4 cycles have been completed for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Arm Title
KER-050 Cohort 2
Arm Type
Experimental
Arm Description
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 4 cycles. Participants have the option to continue to receive KER-050 once 4 cycles have been completed for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Arm Title
KER-050 Cohort 3
Arm Type
Experimental
Arm Description
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Arm Title
KER-050 Cohort 4
Arm Type
Experimental
Arm Description
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Arm Title
KER-050 Cohort 5
Arm Type
Experimental
Arm Description
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Arm Title
KER-050 Dose Confirmation Cohort
Arm Type
Experimental
Arm Description
Participants to receive KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Intervention Type
Drug
Intervention Name(s)
KER-050
Intervention Description
KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles in a Long-Term Extension.
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Description
Type, frequency, severity of AEs and relationship of AEs to KER-050
Time Frame
From treatment initiation to end of study, approximately 2 years
Secondary Outcome Measure Information:
Title
Maximum concentrations of KER-050
Description
Pharmacokinetics of KER-050
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Erythroid response in low-transfusion burden (LTB) and high-transfusion burden (HTB) participants.
Description
In LTB participants, the proportion of participants who have a hemoglobin increase of ≥ 1.5 g/dL from Baseline for ≥ 14 days (in the absence of RBC transfusions).
In HTB participants, the proportion of participants having a reduction of ≥ 50% or ≥ 4 RBC units transfused compared to pretreatment over an 8-week period.
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Incidence of progression to higher risk MDS or AML per World Health Organization 2016 criteria
Description
Change in baseline laboratory assessments prior to treatment with KER-050 and after treatment with KER-050
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Incidence of progression to higher risk MDS or AML per World Health Organization 2016 criteria
Description
Change in baseline bone marrow assessments prior to treatment with KER-050 and after treatment with KER-050
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Modified 2006 International Working Group (IWG) Hematologic Improvement Erythroid (HI-E) response
Description
In LTB participants, the proportion of participants with an increase of ≥ 1.5 g/dL from pretreatment hemoglobin during any 8-week period on study compared to Baseline.
In HTB participants, the proportion of participants having a reduction by ≥ 4 units of RBCs transfused (for a hemoglobin ≤ 9.0 g/dL) during any 8-week period on study, compared with the 8-week period prior to study Cycle 1 Day 1.
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Mean change from baseline in hemoglobin
Description
Change in baseline hemoglobin prior to treatment with KER-050 and after treatment with KER-050
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Time to erythroid response and modified 2006 IWG HI-E response
Description
Time to erythroid response prior to treatment with KER-050 and after treatment with KER-050
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Duration of erythroid response and modified 2006 IWG HI-E response
Description
Duration of erythroid response prior to treatment with KER-050 and after treatment with KER-050
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Frequency of red blood cell (RBC) transfusions and rate of RBC transfusion independence ≥ 8 weeks
Description
Frequency and rate of RBC transfusions prior to treatment with KER-050 and after treatment with KER-050
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
Title
Change from Baseline in RBC counts and reticulocytes
Description
Change in baseline RBC counts and reticulocytes prior to treatment with KER-050 and after treatment with KER-050
Time Frame
Measured at multiple timepoints over the course of study from study day 1 to end of study, approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease.
< 5% blasts in bone marrow.
Peripheral blood white blood cell count <13,000/µL.
Anemia defined as:
In non-transfused participants, having received no red blood cell (RBC) transfusions within 8 weeks Hgb concentration ≤ 10.0 g/dL OR
In LTB participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL within 8 weeks OR
In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.
Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.
Key Exclusion Criteria:
Any active infection requiring parenteral antibiotic therapy within 28 days prior to Cycle 1 Day 1 or oral antibiotics within 14 days of Cycle 1 Day 1.
Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
Vitamin B12 deficiency.
Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
Treatment within 28 days prior to Cycle 1 Day 1 with:
Erythropoiesis stimulating agent (ESA) OR
Granulocyte colony-stimulating factor (G-CSF) OR
Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
Treatment with another investigational drug or device or approved therapy for investigational use < or = 28 days prior to Cycle 1 Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer.
Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
Transferrin saturation < 15%.
Ferritin < 50 µg/L.
Folate < 4.5 nmol/L (< 2.0 ng/mL).
Vitamin B12 < 148 pmol/L (< 200 pg/mL).
Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
Pregnant or lactating females
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Study Team
Phone
+1 (617) 314-6297
Email
ker050-md-201@kerostx.com
Facility Information:
Facility Name
University of Miami, Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikkael A Sekeres, MD
First Name & Middle Initial & Last Name & Degree
Mikkael A Sekeres, MD
Facility Name
H. Lee Moffitt Cancer Center and Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami Komrokji
Facility Name
University of Pittsburgh Medical Health Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Redner
Facility Name
Border Medical Oncology Research Unit
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anish Puliyayil
Facility Name
The Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Arbelaez
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kwan
Facility Name
Townsville University Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Wight
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devendra Hiwase
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ross, MD
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tse-Chieh Teh
Facility Name
University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Rose
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Fong
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynette Chee
Facility Name
St Vincent's Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuh Ying Tan
Facility Name
Ballarat Oncology and Haematology Service
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Kannourakis, MD
Facility Name
Fakultni Nemocnice Brno
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiri Mayer
Facility Name
Fakultni Nemocnice Kralovske Vinohrady
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Cerna
Facility Name
Vseobecna Fakultni Nemocnice Praha
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Jonasova
Facility Name
CHU Angers - Hôpital Hôtel Dieu
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Thepot
Facility Name
CHU de Nantes - Hotel Dieu
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Garnier
Facility Name
CHU Nice - Hôpital de l'Archet
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Cluzeau
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Ades
Facility Name
CH René-Dubos
City
Pontoise
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riad Benramdane
Facility Name
CHU de Bordeaux - Hôpital Haut-Lévêque
City
Talence
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Dimicoli Salazar
Facility Name
Centre Hospitalier de la Région d'Annecy
City
Épagny
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha Mauz
First Name & Middle Initial & Last Name & Degree
Charlotte Doublet
Facility Name
Klinikum Bayreuth GmbH
City
Bayreuth
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Kiani
Facility Name
Marien Hospital Dusseldorf GMBH
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aristoteles Giagounidis
Facility Name
Universitaetsklinikum Duesseldorf AoeR
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Germing
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swen Wessendorf
Facility Name
Universitaetsklinikum Leipzig AoeR
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Kubasch
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Sasca
Facility Name
Universitaetsmedizin Rostock
City
Rostock
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Wittke
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drorit Merkel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yakir Moshe
Facility Name
Middlemore Hospital
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Liang
Facility Name
Hospital Universitario Central de Asturias
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Bernal del Castillo
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David V Ferreiras
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montserrat Sangerman
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Campelo
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Gonzalez
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Santillana
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of KER-050 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
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